Description and Brand Names

US Brand Name

PROzac

PROzac Weekly

Rapiflux

Sarafem

Selfemra

Canadian Brand Name

Phl-FLUoxetine

Descriptions

Fluoxetine is used to treat depression, obsessive-compulsive disorder (OCD), bulimia nervosa, premenstrual dysphoric disorder (PMDD), and panic disorder. It is also used together with olanzapine to treat depression that is part of bipolar disorder.

Fluoxetine is an antidepressant and belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). This medicine works by increasing the activity of a chemical called serotonin in the brain.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Capsule

Capsule, Delayed Release

Tablet

Syrup

Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluoxetine in children. However, safety and efficacy have not been established to treat depression in children younger than 8 years of age, and to treat obsessive-compulsive disorder in children younger than 7 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of fluoxetine in children with bulimia nervosa or panic disorder. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluoxetine in the elderly. However, elderly patients are more likely to have hyponatremia (low sodium in the blood) than younger adults, which may require caution and an adjustment in the dose for patients receiving fluoxetine.

Pregnancy

Information about this fluoxetine-oral-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amifampridine

Bepridil

Bromopride

Cisapride

Clorgyline

Dronedarone

Furazolidone

Iproniazid

Isocarboxazid

Levomethadyl

Linezolid

Mesoridazine

Methylene Blue

Metoclopramide

Moclobemide

Nialamide

Pargyline

Phenelzine

Pimozide

Piperaquine

Procarbazine

Rasagiline

Safinamide

Saquinavir

Selegiline

Sparfloxacin

Terfenadine

Thioridazine

Toloxatone

Tranylcypromine

Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab

Abiraterone

Acecainide

Aceclofenac

Acemetacin

Acenocoumarol

Ajmaline

Alfuzosin

Almotriptan

Amineptine

Amiodarone

Amisulpride

Amitriptyline

Amitriptylinoxide

Amoxapine

Amtolmetin Guacil

Anagrelide

Ancrod

Anisindione

Antithrombin III Human

Apixaban

Apomorphine

Aprindine

Ardeparin

Argatroban

Aripiprazole

Arsenic Trioxide

Asenapine

Aspirin

Astemizole

Atazanavir

Azimilide

Azithromycin

Bedaquiline

Bemiparin

Bivalirudin

Bretylium

Brexpiprazole

Bromfenac

Brompheniramine

Bufexamac

Buprenorphine

Bupropion

Buserelin

Cangrelor

Carbamazepine

Celecoxib

Certoparin

Chloral Hydrate

Chloroquine

Chlorpheniramine

Chlorpromazine

Choline Salicylate

Cilostazol

Cinacalcet

Ciprofloxacin

Citalopram

Clarithromycin

Clomipramine

Clonixin

Clopidogrel

Clozapine

Cobicistat

Cocaine

Crizotinib

Cyclobenzaprine

Dabigatran Etexilate

Dabrafenib

Dalteparin

Danaparoid

Dasatinib

Defibrotide

Degarelix

Delamanid

Dermatan Sulfate

Desipramine

Desirudin

Deslorelin

Desvenlafaxine

Dexfenfluramine

Dexibuprofen

Dexketoprofen

Dextromethorphan

Dibenzepin

Diclofenac

Dicumarol

Diflunisal

Dipyridamole

Dipyrone

Disopyramide

Dofetilide

Dolasetron

Domperidone

Donepezil

Doxepin

Doxorubicin

Doxorubicin Hydrochloride Liposome

Droperidol

Drotrecogin Alfa

Droxicam

Duloxetine

Ebastine

Edoxaban

Efavirenz

Eletriptan

Eliglustat

Enflurane

Enoxaparin

Epoprostenol

Eptifibatide

Eribulin

Erythromycin

Escitalopram

Etodolac

Etofenamate

Etoricoxib

Famotidine

Felbamate

Felbinac

Fenfluramine

Fenoprofen

Fentanyl

Fepradinol

Feprazone

Fingolimod

Flecainide

Floctafenine

Fluconazole

Flufenamic Acid

Fluphenazine

Flurbiprofen

Fluvoxamine

Fondaparinux

Formoterol

Foscarnet

Fosphenytoin

Frovatriptan

Galantamine

Gatifloxacin

Gemifloxacin

Gonadorelin

Goserelin

Granisetron

Halofantrine

Haloperidol

Halothane

Heparin

Histrelin

Hydroquinidine

Hydroxychloroquine

Hydroxytryptophan

Hydroxyzine

Ibuprofen

Ibuprofen Lysine

Ibutilide

Iloperidone

Iloprost

Imipramine

Indomethacin

Iobenguane I 123

Isoflurane

Isradipine

Itraconazole

Ivabradine

Ketoconazole

Ketoprofen

Ketorolac

Lapatinib

Lepirudin

Leuprolide

Levofloxacin

Levomilnacipran

Lidoflazine

Lofepramine

Lorcaserin

Lornoxicam

Loxoprofen

Lumefantrine

Lumiracoxib

Meclofenamate

Mefenamic Acid

Mefloquine

Melitracen

Meloxicam

Meperidine

Methadone

Metronidazole

Mifepristone

Milnacipran

Mirtazapine

Mizolastine

Morniflumate

Moxifloxacin

Nabumetone

Nadroparin

Nafarelin

Naproxen

Naratriptan

Nebivolol

Nefazodone

Nepafenac

Niflumic Acid

Nilotinib

Nimesulide

Nimesulide Beta Cyclodextrin

Norfloxacin

Nortriptyline

Octreotide

Olanzapine

Ondansetron

Opipramol

Oxaprozin

Oxycodone

Oxyphenbutazone

Paliperidone

Palonosetron

Panobinostat

Parecoxib

Parnaparin

Paroxetine

Pasireotide

Pazopanib

Pentamidine

Pentazocine

Pentosan Polysulfate Sodium

Perflutren Lipid Microsphere

Perphenazine

Phenindione

Phenprocoumon

Phenylbutazone

Piketoprofen

Pimavanserin

Pirmenol

Piroxicam

Pitolisant

Posaconazole

Prajmaline

Pranoprofen

Prasugrel

Probucol

Procainamide

Prochlorperazine

Proglumetacin

Promethazine

Propafenone

Propionic Acid

Propranolol

Propyphenazone

Proquazone

Protein C

Protriptyline

Quetiapine

Quinine

Ranolazine

Reviparin

Rilpivirine

Risperidone

Ritonavir

Rivaroxaban

Rizatriptan

Rofecoxib

Salicylic Acid

Salsalate

Selexipag

Sematilide

Sertindole

Sertraline

Sevoflurane

Sibutramine

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Sodium Salicylate

Solifenacin

Sorafenib

Sotalol

Spiramycin

St John's Wort

Sulfamethoxazole

Sulfinpyrazone

Sulindac

Sulpiride

Sultopride

Sumatriptan

Sunitinib

Tacrolimus

Tamoxifen

Tapentadol

Tedisamil

Telavancin

Telithromycin

Tenoxicam

Terbinafine

Tetrabenazine

Tianeptine

Tiaprofenic Acid

Ticagrelor

Ticlopidine

Tinzaparin

Tirofiban

Tizanidine

Tolfenamic Acid

Tolmetin

Tolterodine

Toremifene

Tramadol

Trazodone

Treprostinil

Trifluoperazine

Trimethoprim

Trimipramine

Triptorelin

Tryptophan

Valdecoxib

Vandetanib

Vardenafil

Vasopressin

Vemurafenib

Venlafaxine

Vilazodone

Vinflunine

Vorapaxar

Voriconazole

Vorinostat

Vortioxetine

Warfarin

Zolmitriptan

Zotepine

Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alprazolam

Buspirone

Cyproheptadine

Delavirdine

Digoxin

Ginkgo

Lithium

Phenytoin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Bipolar disorder (mood disorder with mania and depression), or risk of or

Bleeding problems or

Diabetes or

Glaucoma (angle-closure type) or

Hyponatremia (low sodium in the blood) or

Mania, history of or

Seizures, history of—Use with caution. May make these conditions worse.

Heart attack or stroke, recent or history of or

Heart failure or

Heart rhythm problems (eg, QT prolongation), or history of or

Hypokalemia (low potassium in the blood) or

Hypomagnesemia (low magnesium in the blood)—May cause side effects to become worse.

Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine only as directed by your doctor, to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take the medicine with or without food.

For some conditions, it may take a month or longer before you begin to feel better.

If you are using the oral liquid, shake the bottle well before measuring each dose. Measure the liquid with a marked measuring spoon, oral syringe, or medicine cup. A regular household teaspoon will not measure the proper amount of medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Adults—At first, 20 milligrams (mg) per day as a single dose in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day. After a few weeks, your doctor may change you to a weekly dose of 90 mg, taken as a single dose one day per week.

Children 8 years of age and older—At first, 10 to 20 mg per day as a single dose in the morning. Your doctor may adjust your dose as needed.

Children younger than 8 years of age—Use and dose must be determined by your doctor.

For obsessive-compulsive disorder:

Adults—At first, 20 milligrams (mg) per day as a single dose in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day.

Children 7 years of age and older—At first, 10 mg per day as a single dose in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.

Children younger than 7 years of age—Use and dose must be determined by your doctor.

For panic disorder:

Adults—At first, 10 milligrams (mg) per day as a single dose in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.

Children—Use and dose must be determined by your doctor.

For premenstrual dysphoric disorder:

Adults—At first, 20 milligrams (mg) per day as a single dose in the morning. Your doctor may have you take 20 mg every day of your menstrual cycle or for only 15 days of your cycle. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is important that your doctor check your progress at regular visits, to allow changes in your dose and help reduce any side effects. Blood tests may be needed to check for unwanted effects.

Do not take fluoxetine with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking fluoxetine during the 2 weeks after you stop a MAO inhibitor and wait 5 weeks after stopping fluoxetine before you start taking a MAO inhibitor. If you take them together or do not wait the proper amount of time, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Do not take thioridazine (Mellaril®) with fluoxetine and wait 5 weeks after stopping fluoxetine before you start taking thioridazine. Do not use pimozide (Orap®) with fluoxetine. Using these medicines together can cause very serious heart problems.

Fluoxetine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use fluoxetine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, or some pain or migraine medicines (eg, rizatriptan, sumatriptan, tramadol, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with fluoxetine.

Fluoxetine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This will decrease the chance of having withdrawal symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

Tell your doctor right away if you develop a rash or hives, swelling of the face, eyes, or mouth, or trouble breathing after taking this medicine.

This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, nonsteroidal antiinflammatory agents, also called NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

Hyponatremia (low sodium in the blood) may occur with this medicine. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

Contact your doctor right away if you have dizziness, fainting, or a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you have ever had a heart rhythm problem, such as QT prolongation, or if you or a family member has had a heart attack, heart failure, low blood pressure, or a stroke.

The use of alcohol is not recommended in patients who are taking fluoxetine.

For diabetic patients:

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

This medicine may cause some people to become drowsy or less able to think clearly, or to have poor muscle control. Make sure you know how you react to fluoxetine before you drive, use machines, or do anything else that could be dangerous if you are not alert and well able to control your movements.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Hives, itching, or skin rash

inability to sit still

restlessness

Less common

Chills or fever

joint or muscle pain

Rare

Anxiety

cold sweats

confusion

convulsions (seizures)

cool pale skin

diarrhea

difficulty with concentration

drowsiness

dryness of the mouth

excessive hunger

fast or irregular heartbeat

headache

increased sweating

increased thirst

lack of energy

mood or behavior changes

overactive reflexes

purple or red spots on the skin

racing heartbeat

shakiness or unsteady walk

shivering or shaking

talking, feeling, and acting with excitement and activity you cannot control

trouble with breathing

unusual or incomplete body or facial movements

unusual tiredness or weakness

Incidence not known

Abdominal or stomach pain

agitation

back or leg pains

bleeding gums

blindness

blistering, peeling, or loosening of the skin

bloating

blood in the urine or stools

bloody, black or tarry stools

blue-yellow color blindness

blurred vision

chest pain or discomfort

clay-colored stools

constipation

continuing vomiting

cough or dry cough

dark urine

decreased urine output

decreased vision

depression

difficulty with breathing

difficulty with swallowing

dizziness or lightheadedness

eye pain

fainting

fast, pounding, or irregular heartbeat or pulse

general body swelling

high fever

hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Decreased appetite

Less common or rare

Abnormal dreams

breast enlargement or pain

change in sense of taste

changes in vision

feeling of warmth or heat

flushing or redness of the skin, especially on face and neck

frequent urination

hair loss

increased appetite

increased sensitivity of the skin to sunlight

menstrual pain

stomach cramps, gas, or pain

unusual secretion of milk, in females

weight loss

yawning

Incidence not known

Cracks in the skin

loss of heat from the body

painful or prolonged erections of the penis

scaly skin

swelling of the breasts or breast soreness in both females and males

unusual milk production

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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